Registration Dossier
Registration Dossier
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EC number: 944-390-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test material caused skin corrosion in the EpiSkin test (OECD GL 431) after 4 hours of exposure but not after 1 hour or 3 minutes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion/irritation
EpiSkinTM SM test of the test material has been performed to predict its corrosion potential by measurement of its cytotoxic effect, as reflected in the MTT assay according to the OECD Test Guideline No. 431, 28 July 2015. NaCl (9 g/L saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively.
Since according to the first experiment results the test material was corrosive after 4 hours exposition, an additional experiment was performed. In this experiment, the 4 hours exposure was repeated and an additional 3 minutes and 1 hour exposure period included.
Disks of EPISKIN (two units) were used for each test item exposure period as well as for negative and positive control.
For each treated tissue viability was expressed as a % relative to negative control. The test material is considered to be non-corrosive to skin, if the mean relative viability after 4 hours of exposure is above or equal 35 % of the negative control.
The test material showed significantly reduced cell viability (below 35 %) in comparison to the negative control after 4 hours of exposure in both experiments. In the first experiment the average test material treated tissue viability was 15% and in the additional experiment 1% at 4 hours of exposure.
In the additional experiment the test material treated tissue viabilities were above 35 % of the mean negative control value after 1 hour and 3 min of exposure (82 % at 1 hour and 101 % at 3 minutes of exposure).
Positive and negative controls showed the expected cell viability values within acceptable limits. All assay acceptance criteria were met, the experiment was considered to be valid.
In conclusion, in this in vitro EpiSkin skin corrosion test the results indicate that the test material is corrosive to skin after 4 hours exposure and not corrosive after 1 hour and 3 minutes exposure. According to the UN GHS classification systems, the test material has been categorized as “Corrosive: Optional Sub- categories 1B and 1C”.
Eye irritation
No exerimental data is available. Since the test material is corrosive to skin it is considered to cause severe eye damage..
Justification for classification or non-classification
The test material was corrosive in the EpiSkin model after 4 -hours of exposure. As a result the substance requires classification for corrosion (Cat. 1 (B or C)); H314: Causes severe skin burns and eye damage under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.
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